China's new biosimilars guideline: more flexibility, but stricter in parts
This article was originally published in SRA
Executive Summary
The China Food and Drug Administration has released the final version of its biosimilars guideline1.
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China's new biosimilars guideline: more flexibility, but stricter in parts
Three months after publishing its draft guideline on biosimilars, China's Food and Drug Administration (CFDA) has just released the final official version, although it is still described as a pilot scheme. The new guideline may look similar to the draft on the surface, but a closer comparison reveals many differences.